Heroes Not Zombies

Robert Ader is the forefather of the whole area of study known as psychoneuroimmunology (PNI). It amazes me that so few current graduates of medical schools have even heard of the term. Although it’s quite a mouthful, it is, simply, the study of the inter-relationships between the mind, the nervous system and the immune system. Together with psychoneuroendocrinology (the study of the mind, nervous system and endocrine system links), these areas of scientific study begin to help us to understand how the human being functions as a whole organism and how it’s pointless to consider the body and the mind as two distinct, separate entities.

He’s just published an interesting study on the clinical use of placebo. Starting from the understanding of the placebo effect as being, at least in part, akin to psychological, behavioural conditioning, and that such conditioning can exert physical changes in the body, he and his colleagues studied a group of patients with psoriasis.

They split the patients into three groups. One group applied a specified amount of steroid cream daily to their lesions, a second applied 25 to 50% of the strength of the steroid cream daily, and a third group applied cream which 25 to 50% of the time contained the full strength steroid and the rest of the time was a placebo (no steroid present).

The results are interesting, showing in particular that the group which received the placebo some of the time did as well as those receiving the full strength cream all the time, and better than the group receiving the lesser strength cream daily.

So what? Well, Ader and his colleagues point out that using placebo in this way could significantly reduce the amount of a drug required to have a desired outcome. Less drug means less side effects and less cost.

This is a novel study. Can the same phenomenon be found when applied to patients with other conditions? And for those who are concerned about the ethics, this was a fully informed, fully consented trial. There’s no reason why patients clinically couldn’t be given the choice to have treatments in this way……especially if further research confirms that the clinical outcomes are as good as using higher doses of drug more frequently.

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Last week’s BMJ and Channel 4 News highlighted the highly dubious evidence base for Tamiflu.

In the process of updating their review, Jefferson et al found several important inconsistencies. Prompted by a reader of their previous update, they attempted to reconstruct the evidence from a much cited analysis on which they had based their previous conclusions. The analysis, by Kaiser et al, looked specifically at the effects of oseltamivir on the risk of hospital admission and complications (pneumonia and other lower respiratory tract infections) in people with influenza. Jefferson et al noted that the Kaiser analysis was funded by the drug’s manufacturer Roche and was based entirely on 10 trials funded by Roche, only two of which had been published as articles in peer reviewed journals. All 10 included trials were authored by Roche employees and paid academic consultants. The Cochrane reviewers could find no independently funded trials of oseltamivir in healthy adults.

Independant researchers have

concluded that they have no confidence in claims that oseltamivir reduces the risk of complications and hospital admission in people with influenza.1 In doing so they have reached a similar conclusion to the Food and Drug Administration in the United States and the recent health technology assessment performed for the UK’s National Institute for Health and Clinical Excellence (NICE), which both conclude that there is insufficient evidence on complications

So, why has the UK government given £500 Million (yes, £500 MILLION) pounds to Roche to buy massive supplies of this drug? (In the US, they’ve spend about one and half billion dollars on it)

The issue of what does Tamiflu do if it doesn’t significantly reduce the chances of complications of hospital admissions has been summarised as reducing the duration of flu by about half a day.

The £500 million drug cost isn’t the whole problem. By setting up a flow-chart based telephone prescribing system Tamiflu has been given to hundreds of thousands of people without a proper diagnosis of influenza or swine flu. If you can’t start with the right diagnosis, how do you ever get the patient the right treatment?

So, what’s the explanation for the government’s strategy for managing  the “swine flu pandemic”?

Is this a good example of “evidence based medicine”? Is it a good example of rational practice or cost-effective practice in the NHS? I don’t think so

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There’s a pretty substantial number of references to research showing health benefits from the practice of Transcendental Meditation (TM), but a new piece of research is especially interesting. The Medical College of Wisconsin carried out a study of 201 African American men and women who had heart disease (average age, 59). They were randomised in two groups. One group were given lifestyle education (diet, exercise etc), and the other group was taught how to practice TM. After 9 years the TM group had a 47% reduction in deaths, heart attacks and strokes (20 “events” in the TM group, and 31 in the education group). The average blood pressure was also significantly lower in the TM group 9 years on.

It’s good to see studies of non-drug methods of improving health outcomes. It was interesting, however, to see how the BBC headed up the report “Meditation ‘eases heart disease’ ” – funny how drugs get reported almost as miracle cures but meditation reducing deaths, heart attacks and strokes by 47% gets described as “easing” heart disease!

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A study published in Science last week reports finding a high incidence of XMRV in patients with chronic fatigue. XMRV stands for “xenotropic murine leukemia virus-related” virus and is a retrovirus which seems to have jumped species from mice to men.

Dr. Mikovits and researchers from the National Cancer Institute and the Cleveland Clinic reported in Science that 68 of 101 patients with chronic fatigue syndrome, or 67 percent, were infected with XMRV, compared with only 3.7 percent of 218 healthy control subjects. Further testing after the paper was written found the virus in nearly 98 percent of about 300 patients with the syndrome, Dr. Mikovits said.

This is interesting, but the way it’s been reported is disturbing. The authors are claiming that it may be the “sole” cause of “ME”. I think that’s highly unlikely because “ME”, or “CFS”, is a poorly understood syndrome which probably encompasses a number of different aetiologies and illnesses. On the back of that, they’re predicting a bright future for the treatment of the condition using antiviral drugs and developing vaccines. Woa! Too fast! You can just hear the drug companies rubbing their hands with glee! This constant portrayal of complex illness in simplistic terms results in products being matched to diagnoses, instead of individuals being understood and enabled to experience healthy, natural recovery. (as a side note, I think you can conceptualise such complex disorders as failures of the body’s normal healing processes. Something precipitated the ill state, and for whatever reasons, the patient has developed a chronic condition of low vitality, poor resilience and ill health).

The second disturbing aspect of this report is how both sufferers and medical professionals have jumped on this as a possible “legitimation” of the illness. As if finding evidence of a virus now makes the disorder “real”, or “not a mental disorder”, or even illusory. OK, if this connection is established and results in sufferers being listened to, and taken seriously, then I can see that as a benefit, but why can’t they be listened to and taken seriously even without finding a virus?

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Oh how little we understand about the so-called “placebo response”. Here’s an interesting study to throw into the mix. Apparently, the actual symptoms experienced by “placebo responders” in clinical trials accurately mimic the drugs being tested. The likely ill-effects reported by those who took a placebo in a trial are likely to be just like the ill-effects experienced by those who took the active drug.
What does this mean?
Well, if it’s truly a double-blinded study, how does the volunteer know what side-effects are likely? Some commentators have dismissed this finding as down to expectations but how did the volunteers know what to expect? I think this phenomenon needs to be studied rather more closely. If the volunteers, through the process of informed consent, are being made aware of the type of drug being tested and/or the possible effects it might have, then maybe this phenomenon will manifest itself more strongly than it would in a group of volunteers who really didn’t have a clue what they were (possibly) taking. If this were the case, then the expectation explanation might hold water. But if it turned out not to be the case, then how do we explain it? Morphogenetic fields? Collective unconsciousness?
I do wish the incredible rich variety of responses of the human being to therapeutic interventions was not reduced to such simplistic notions of a “placebo” (by which the researcher means, “nothing”).
Life is more complex than that.

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Was HPV vaccination responsible for the death of that little girl in England last week? We live in a society where simplistic and judgmental conclusions seem to be both valued and common. In response to that news story you’ll have read some people argue that the vaccine isn’t safe, and others argue that it had absolutely nothing to do with the girl’s death.
Is life so simple? Can we really be so certain in relation to cause and effect? I don’t think so.
I often say to patients that when you think about chronic illness, it’s rare to be able to ascertain a single cause. In the vast majority of cases it’s far better to think about the multiplicity of factors and influences which have challenged the person, and to think about the dynamic, continually changing ways a person responds to and copes with those challenges.
For example, it appears this girl had a tumour “heavily infiltrating” her heart and one lung. It’s highly likely that such a serious pathology would be life threatening. The presence of that disease meant she was considerably more vulnerable and more fragile than other girls in her class. So did the vaccination provoke her final, fatal incident? Sadly, the truth is, we’re not clever enough to be able to know. In fact, until we stop thinking of human beings as simple machines where this leads directly to that, we’ll never be clever enough to know. We don’t have the equipment to show the complex behaviour of the whole organism. So to say that the advocates of the vaccination could “breathe a sigh of relief” was not just insensitive, it was wrong.
The fact that 1.4 million doses of this vaccine have been administered without any deaths is reassuring to everyone except Natalie Morton’s parents.
Human beings are not reducible to numbers. In yesterday’s Guardian there was a sensitive exploration of the difference between making a Public Health announcement and making a decision about a member of your own family.
Is vaccination a biological challenge? Yes, it is. If it were no challenge there would be no provocation of the immune response. Can a biological challenge be fatal? Absolutely. An anaphylactic reaction to a bee sting in a previously fit and healthy person can be fatal. Much lesser challenges can be fatal in an already vulnerable, compromised individual. Rather than dismiss the role of HPV vaccination in this tragic case, wouldn’t we be better served by improving the screening procedures before mass vaccination? Shouldn’t we make a better attempt to assess the fitness of the individual to receive this challenge?
Maybe it’s not easy to find such answers, or to live with uncertainty, but outright dismissal of risk by simplistic explanations and population-based statistics, really don’t inspire confidence.

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There really are many definitions of health, and that’s not a bad thing. Such a complex phenomenon cannot be wholly understood by the use of a sound bite, a mission statement, or a simple formula. However, a simple statement or formula can provoke thought, change a perspective, or shine a light on a poorly understood issue.
Here’s one simple statement about health

Vitality + Resilience = Health

When someone is sick they seek a restoration of health. They, preferably, want a cure. Something which will completely remove all traces of the disease and leave them back where they were before they became ill (or, maybe even in a better place than they were to start with!). In acute disease that can be a reasonable aim. Infectious disease is a good example. If you suffer from some infection this winter, say a chest infection, a cold or a flu, then you’ll find that the illness will last a few days after which time, the symptoms will all fade away. You might need the assistance of some anti-infective drug to kill the offending bug but the bottom line is your body will repair itself and the disease will be over. (I’m talking best case scenarios here!) However, chronic diseases are not like that. Chronic diseases involve changes which don’t go away. Despite that two people with the same chronic disease will experience very different levels of health. Two people with the same pathological lesions (similar locations, similar severity) may report completely different levels of well-being, and whilst one may state that the illness is making life unbearable, another may state that life is good, or even that they are flourishing. Eric Cassell, the American physician explores this in his writings by taking a focus his patients’ assessment of their “suffering” and shows that whilst there is a relationship between disease and illness, or, shall we say, between lesions and experience, that it’s not a simple one-to-one relationship.
If we return to the scenario of acute disease for a moment, two people who suffer from the same infection don’t have the same experience. One may get severe or long-lasting symptoms whilst the other experiences only mild, short lived ones. Beyond the period of infection, one person may bounce back fully restored, whilst another finds themselves with lingering symptoms or feeling just under par for several days, or even weeks. What makes the difference?
I think one explanation lies in this simple statement
Vitality + Resilience = Health.
Vitality is not an easy thing to pin down. Some people understand it best as “well-being”, “wellness” or “energy”, but I prefer the word “vitality” because I like it’s positive connotations and I think it captures a sense of vigour or brightness. The opposite of vitality would be debility. It would be reasonable to expect that someone whose vitality is very low will be both more susceptible to catching an infection, and more likely to experience a more severe or prolonged illness. Without good vitality, resilience is impaired.
Resilience is the capacity of a person to cope, to deal with what has happened by repairing damaged tissue or systems, and/or by adapting to the changes in their bodies and their lives. Resilience also involves some kind of growth. When we cope with something, or when we adapt to a major change, then we grow. We grow by having learned something, by having become stronger in some way, more able to deal with challenges perhaps. This kind of growth is a part of resilience. When we grow as a result of our coping and adapting then we become more resilient.
I think both vitality and resilience are important parts of health and I think they’re relevant to the treatment of both acute and chronic diseases. But most treatments used by doctors are not designed to influence either of these phenomena. Why is that? Sure, it’s good to have treatments which directly kill bugs, or which assist the body to address a pathology by having a direct effect on lesions, but if we don’t pay attention to vitality and resilience are we really going to become healthy?
We need to understand vitality and resilience better. We need to better understand how they work, and we need to understand what therapeutic interventions will stimulate vitality and enhance resilience. Then we need to develop that whole aspect of health care because so far, we focus almost exclusively on lesions and disease, not on health.

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How accurate are the published figures about swine flu?

Once the decision was taken to skip swabs and diagnose on symptoms only, the figures have likely to have become very unreliable. Is anyone objectively studying the percentage of those who have a swine flu diagnosis from the questionnaire only, who actually have evidence of swine flu virus, so we can understand just how accurate, or inaccurate the figures are? Reports such as “100,000 new cases of swine flu last week alone” do indeed generate alarm. What are the real figures? If nobody is interested to discover the real figures then maybe at least the reporting should be changed to “100,000 new cases of flu-like illnesses last week”, or something similar.

Why are so many patients being prescribed Tamiflu? What we know about Tamiflu is that it may be able to delay the spread of the virus for a short period of time (but not prevent it’s spread ultimately); that it can shorten the duration of the illness by about a day [Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. JAMA. 2000;283:1016-1024] (but not that it can save lives or even prevent serious complications of the flu); that it is “an unpleasant experience” to take with side effects ranging from nausea, vomiting, and hallucinations to serious, rare effects like Stevens-Johnson Syndrome and toxic epidermal necrolysis .

As we have no evidence that it is safe to take in pregnancy, and best practice would therefore suggest that it should only be prescribed when there is significant threat to the foetus, but that’s not the standard being used. An interview with a pregnant woman on BBC news last week showed her picking up her Tamiflu even though she personally thought she only had a cold, because she’d been advised to take the medication on the basis of “better safe than sorry”.

Finally, if seasonal flu kills 8,000 to 9,000 people every year in England, (and up to 19,000 in 2002), is the management of swine flu leading to a different way of dealing with seasonal flu in the future? Will we now see seasonal flu diagnosable online and by telephone by non-medical staff and the mass prescribing of Tamiflu every winter?

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….stepped out into the garden at work and look what I found!

(emerveillement)

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